Acalabrutinib - Generic Drug Details

What are the generic sources for acalabrutinib and what is the scope of patent protection?

Acalabrutinib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acalabrutinib has one hundred and fifty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for acalabrutinib

International Patents:	159
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	130
Patent Applications:	1,527
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib
What excipients (inactive ingredients) are in acalabrutinib?	acalabrutinib excipients list
DailyMed Link:	acalabrutinib at DailyMed

Recent Clinical Trials for acalabrutinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kite, A Gilead Company	Early Phase 1
Acerta Pharma, LLC	Early Phase 1
Jeremy Abramson, MD	Phase 2

See all acalabrutinib clinical trials

Pharmacology for acalabrutinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Paragraph IV (Patent) Challenges for ACALABRUTINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CALQUENCE	Capsules	acalabrutinib	100 mg	210259	5	2021-11-01

US Patents and Regulatory Information for acalabrutinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes			Y	Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for acalabrutinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Calquence	acalabrutinib	EMEA/H/C/005299 Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.	Authorised	no	no	no	2020-11-05

International Patents for acalabrutinib

Country	Patent Number	Title	Estimated Expiration
Japan	2007509060
Serbia	58177	4-IMIDAZOPIRIDAZIN-1-IL-BENZAMIDI I 4-IMIDAZOTRIAZIN-1-IL-BENZAMIDI KAO INHIBITORI BTK (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK-INHIBITORS)
South Korea	101802689
Japan	2018035184	ＢＴＫ阻害剤としての４−イミダゾピリダジン−１−イル−ベンズアミドおよび４−イミダゾトリアジン−１−イル−ベンズアミド (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK INHIBITORS)
Norway	2021016

Supplementary Protection Certificates for acalabrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	21C1014	France		RODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522	2021C/512	Belgium		PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522	PA2021004	Lithuania		PRODUCT NAME: AKALABRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
2734522	2021016	Norway		PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
2734522	LUC00202	Luxembourg		PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106